Registration Dossier
Registration Dossier
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EC number: 701-276-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methylenediphenyl diisocyanate
- EC Number:
- 247-714-0
- EC Name:
- Methylenediphenyl diisocyanate
- Cas Number:
- 26447-40-5
- IUPAC Name:
- 1,1'-methylenebis(2-isocyanatobenzene)
- Reference substance name:
- benzene, 1,1'-methylenebis[isocyanato
- IUPAC Name:
- benzene, 1,1'-methylenebis[isocyanato
- Details on test material:
- - Name of test material (as cited in study report): Desmodur VP.PU 1806
- Physical state: colorless, clear liquid
- Analytical purity: see composition of test material
- Composition of test material, percentage of components: 2,2'-Diisocyanatodiphenylmethane 0.64%, 2,4'-Diisocyanatodiphenylmethane 53.60% and 4,4'-Diisocyanatodiphenylmethane 45.72%.
- Manufacturer: Bayer AG, Liverkusen
- Stability under test conditions: guaranteed for the study period
- Storage condition of test material: room temperature, in nitrogen
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfaune UK Ltd.
- Mean body weight at study initiation: 3.52 Kg (3.1 - 3.7 Kg)
- Diet (e.g. ad libitum): Standard diet "Ssniff", approx. 100-120 g per animal/day, once per day in the morning
- Water (e.g. ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin site of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 6x6
REMOVAL OF TEST SUBSTANCE
- Washing (if done): carefully washed with water without altering the existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 2.03
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24-48-72 h
- Score:
- 1.43
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 24-48-72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24-48-72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 24-48-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 24-48-72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritant / corrosive response data:
- The reactions extended beyond the exposed area. Eschar formation was observed in 1 animal from 72 h to 7 days and in 2 animals on day 7. The exposed site was covered by a whitish scaly layer in 2 animals after 7 days and in 2 additional animals on day 14.
Any other information on results incl. tables
Animal No. |
DRAIZE grade after |
Mean (24-48-72 h) |
||||||||||||
1h |
24h |
48h |
72h |
7days |
14days |
|||||||||
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
E |
O |
|
1 |
1 |
0 |
2 |
0 |
2 |
0 |
2 |
0 |
2 |
3 |
0 |
0 |
2.0 |
0.0 |
2 |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
2 |
2 |
2 |
0 |
1.3 |
0.0 |
3 |
1 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
3 |
3 |
2 |
0 |
1.3 |
0.0 |
4 |
1 |
0 |
2 |
2 |
2 |
3 |
4 |
3 |
4 |
4 |
2 |
2 |
2.7 |
2.7 |
5 |
0 |
0 |
2 |
2 |
2 |
3 |
3 |
4 |
4 |
4 |
3 |
2 |
2.3 |
3.0 |
6 |
0 |
0 |
2 |
2 |
3 |
3 |
3 |
4 |
4 |
4 |
3 |
2 |
2.7 |
3.0 |
Mean |
0.7 |
0.0 |
2.0 |
1.0 |
1.8 |
1.5 |
2.3 |
1.8 |
3.2 |
3.3 |
2.0 |
1.0 |
||
Mean of 6 animals (24-48-72 h) |
E = 2.03 |
O = 1.43 |
||||||||||||
E: erythema and eschar formation
O: oedema formation
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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